The Pain Biomarker Study: Changes in Circulating Pain Signalling Molecules with Activation of Pain Receptors

Who is this study for? Patients with a primary headache disorder or lumbar radiculopathy
What treatments are being studied? Capsaicin
Status: Enrolling_by_invitation
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

This study investigates molecular and physical biomarkers of headaches in order to better understand mechanisms of these diseases. There are 3 main parts: 1. Use of capsaicin (active ingredient in hot chili peppers) to trigger release of calcitonin gene related peptide - the hypothesis is that this will be different in headache subjects compared to controls (and if so might be used to predict how these patients will respond to certain medications that modulate calcitonin gene-related peptide). Subjects will be given capsaicin as a cream applied to the forehead or the inner nostril, or a hot sauce that is ingested. 2. Use of capsaicin to trigger eye watering - the hypothesis is that oxygen gas will slow down the amount of eye watering. Cluster headache patients respond very powerfully to oxygen gas but to very little else. The mechanism for oxygen is unknown but in rodents there is data that it works on the parasympathetic / lacrimal gland system. This study translates rodent data into humans in a non-invasive way to confirm the mechanism of this very effective treatment. 3. Use of ice water to trigger headaches - brain freeze causes a very short-lived but intense headache that may cause similar biomarker release as other headache disorders. This may be a useful human model for other headache disorders.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• Diagnosis of one of the following: a. Diagnosis of a primary headache disorder according to the International Headache Classification, including migraine with aura, migraine without aura, chronic migraine, tension headache, cluster headache, paroxysmal hemicrania, short-lasting unilateral neuralgiform headache attacks with conjunctival injection and tearing (SUNCT), short-lasting unilateral neuralgiform headache attacks with cranial autonomic symptoms (SUNA), and hemicrania continua; b. Diagnosed by a pain medicine physician with lumbar radiculopathy (possibly including neuropathic features, nerve impingement on MRI, or electromyography (EMG) report suggestive of lumbar radiculopathy); or c. Healthy control subject with no history of debilitating headaches or debilitating back pain / radiculopathy pain, and no headaches or back pain within the previous 3 months.

• Able to provide HIPAA authorization to share prior medical records/imaging

• Age 18 and older

Locations
United States
Texas
The University of Texas Health Science Center at Houston
Houston
Time Frame
Start Date: 2018-03-21
Completion Date: 2026-05-31
Participants
Target number of participants: 371
Treatments
Experimental: Oral capsaicin
Sham_comparator: Oral capsaicin and Medical Air
Experimental: Oral Capsaicin and Low Flow Oxygen
Experimental: Oral capsaicin and High Flow Oxygen
Experimental: Topical capsaicin
Sham_comparator: Topical capsaicin and Medical Air
Experimental: Topical capsaicin and Low Flow Oxygen
Experimental: Topical capsaicin and High Flow Oxygen
Experimental: Intranasal capsaicin
Sham_comparator: Intranasal capsaicin and Medical Air
Experimental: Intranasal capsaicin and Low Flow Oxygen
Experimental: Intranasal capsaicin and High Flow Oxygen
Experimental: Cold water irrigation
Sham_comparator: Cold water irrigation and Medical Air
Experimental: Cold water irrigation and Low Flow Oxygen
Experimental: Cold water irrigation and High Flow Oxygen
Related Therapeutic Areas
Sponsors
Leads: The University of Texas Health Science Center, Houston
Collaborators: University of California, San Francisco

This content was sourced from clinicaltrials.gov

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